European Biopharmaceutical Review

EBR’s Editor, Deborah O’Neil, summarises January’s main themes, and draws on articles that reference the latest industry news and discoveries.

Science and Innovation

Feature

Q&A: eHealth

Mukhtar Ahmed at BioClinica talks to EBR about the thriving popularity of eHealth technologies, and how paperless systems can help to drive better research and patient engagement.

Features

Spotlight

In an industry increasingly reliant on internet-based collaborations, new EMA guidelines requiring digital signatures on most electronic submissions are the way forward for the pharma industry, suggests SAFE-Biopharma’s Jon Weisberg.

Discovery Technology

Features

Microindentation Testing

Markus Fabich at Olympus discusses microindentation analysis – a method for investigating the mechanical characteristics of bone – and how digital light microscopy can streamline this highly intricate process.

MARKETPLACE

Drug Development

Biopharma Outsourcing

Richard Hucker, Ian James, Scott Vincent and Carl Watson at A4P Consulting report a considerable rise in outsourcing activities within drug development among large biopharma and niche companies alike, and share their predictions on future trends.

Regular Feature

Orphan Drugs

Industry advisor Emile Bellott reflects in depth on the recent boom in orphan drug approvals by the FDA, as well as what the next decade holds for this rapidly expanding sector.

Regular Feature

In Brief

Antimicrobial resistance is an increasingly serious concern, and one which is a very real possibility in the 21st century – threatening the achievements of modern medicine and putting patients at risk. EBR Editor Deborah O’Neil looks at what pharma is doing to address a growing crisis

RESEARCH AND DEVELOPMENT

Research Hubs

Leading Edge

With a £200 million funding boost and five newly established research hubs, the UK is taking its place as a world leader in the regenerative medicine market, says David Pan at the UKRMP.

Drug Development

Implementing Automation

With the average cost of developing a new medicine estimated at $2.6 billion, cost reduction and reducing time to market have become an increasing focus. Implementing an automated quality management system can streamline processes, states MasterControl’s Lane Hirning.

Drug Development

Time to Market

The rush to get a new drug approved does not have to mean a trade-off between cost and safety, believes Clinovo’s Glenn Keet, who reveals how current tech innovations can bolster safety while accelerating time to market.

Drug Development

Early-Stage Development

The EMA's new Adaptive Pathways Network – designed to support early patient access to new medicines in areas of high unmet medical need – could significantly lower drug development costs, claims Karine Kleinhaus at Pluristem Therapeutics.

Feature

Preclinical Safety Assessment

John Carter and Robert Guest at Envigo consider how in vitro assays are helping to steer the development of alternatives to animal-based toxicity testing.

CELL-BASED RESEARCH

Therapeutic Advances

Q&A: Stem Cell Lines

Takara Bio Europe’s Kristina Runeberg describes iPS – a new technology that is able to derive hepatocytes from multiple induced pluripotent cells, and which subsequently shortens the drug development process.

Features

Genetic Modification

2015 was a breakthrough year for biomedicine, thanks to the discovery of a new gene-editing tool, CRISPR/Cas9. Regina Au from BioMarketing Insight discovers how this revolutionary system could potentially wipe out numerous diseases.

THERAPEUTIC DEVELOPMENT

Cell Therapy

World View

Cecilia Van Cauwenberghe at Frost & Sullivan explores the potential of regenerative medicine in combatting major diseases, and finds that each market region approaches this lucrative sector very differently.

Therapeutic Advances

Antibody Engineering

From
CDR grafting and phage display to transgenic mice approaches, the past
two decades have seen rapid advances in humanisation techniques to
reduce immunogenicity. So why are humanised murine antibodies still
being used in today’s labs? Andrew Glover at Fusion Antibodies
investigates.

Therapeutic Advances

Viral Vector Techniques

Recent innovations in viral vector technologies are helping to tackle the challenges of traditional vaccination systems – including complex manufacturing processes. But certain obstacles need to be addressed before these methods can go to market, explains Carl Christel at Sirion Biotech.

Regenerative Medicine

Lab Technology

From generating organs using 3D printing to lab-grown tissues, regenerative medicine has progressed significantly in recent years. BioMarketing Insight's Regna Au examines the key developments in a field that has contributed hugely to the fight against life-threatening diseases.

When it comes to implementing a risk-based monitoring program, it is not
just about reducing monitoring visits and doing less Source Document
Verification (SDV). It’s about bringing together your people, a solid
process, and the right technology to run a better trial.
Success
with risk-based monitoring requires the ability to make sense of the
thousands, if not millions, of data points captured by multiple
disparate sources in a clinical trial. With the sheer volume of data
generated on a daily basis comes complexity. How does one make sense of
it all? Information overload burdens even the most experienced study
teams who struggle to understand which data matters most and what it
means.
More info >>

This year’s Outsourcing in
Clinical Trials event builds on last year’s incredibly successful conference
which will once again be returning to North Carolina with the aim of supporting
trial sponsors and solution providers in the RTP and neighboring regions,
ensuring trials are delivered on time and partnerships are bettered.More info >>